Intracavernous injection of stem cell-derived bioactive molecules for erectile dysfunction—a pilot phase non-randomized controlled trial

2021 ◽  
pp. 1

Background and objective: Experimental and few clinical studies have indicated great potential of stem cell treatments as both a causal and symptomatic approach for the treatment of male erectile dysfunction (ED). We investigated the effect of a one-time injection of stem-cell derived bioactive molecules in patients with self-reported ED. Materials and methods: Twenty self-referred male patients with at least one-year history of ED received a one-time intra-penile injection of acellular stem cell-derived bioactive molecules. ED was evaluated by the International Index of Erectile Function questionnaire (IIEF-5), and quality of life was assessed by the Short-Form-36 questionnaire, (SF-36) at baseline and at 6 months. Six male patients with ED, who received a similar injection using saline served as a historic control. Primary outcome was erectile function as measured by IIEF-5 scores. Secondary outcomes were quality of life, assessed by SF-36 questionnaire. Results: IIEF-5 scores improved from 12.9 ± 4.47 at baseline to 18 ± 3.37 at follow-up (p < 0.05). No significant difference of IIEF-5 scores were observed in the historic controls during the observation period (11 ± 2.53 at baseline vs 10.67 ± 3.5 at follow-up; p > 0.05). Patients, who received stem cell injections, demonstrated significantly enhanced IIEF-5 scores compared to the historic control (p < 0.05). Quality of life scores were significantly improved (role limitations due to physical health issues 56.25 ± 42.82 at baseline vs 68.75 ± 40.45 at follow-up, p < 0.05, energy 51.57 ± 19.33 at baseline vs 57.75 ± 12.3 at follow-up, p < 0.05, emotional wellbeing 56.32 ± 16.28 at baseline vs 68.1 ± 11.73 at follow-up, p < 0.05, and social functioning 67.5 ± 23.79 at baseline vs 76.25 ± 18.98 at follow-up, p < 0.05). Conclusions: A one-time intracavernous acellular stem cell-derived bioactive molecule injection improves IIEF-5 scores and quality of life in men with ED in this small pilot phase study (ClinicalTrials.gov Identifier: NCT04684602).

2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.


2021 ◽  
Author(s):  
Rose K Sia ◽  
Denise S Ryan ◽  
Daniel I Brooks ◽  
Janice M Kagemann ◽  
Kraig S Bower ◽  
...  

ABSTRACT Purpose The purpose of this study was to assess visual and health-related quality of life (QOL) among U.S. military service members who sustained combat ocular trauma (COT) with or without associated traumatic brain injury (TBI). Methods This was a single-center, prospective observational study of U.S. service members (n = 88) with COT who were treated at Walter Reed National Military Medical Center. Participants completed the National Eye Institute Visual Function Questionnaire (VFQ-25) at enrollment and at follow-up (&gt;1 year) and supplemental surveys: Neurobehavioral Symptom Inventory, the Medical Outcomes 36-item Short Form Survey (SF-36), and Mayo-Portland Adaptability Inventory. Results Initial and follow-up VFQ-25 showed a statistically significant increase in median scores for near activities (initial: 75.0, follow-up 83.3; P = .004) and peripheral vision (initial: 50.0, follow-up: 75.0; P = .009) and in composite scores (initial: 79.5, follow-up: 79.8; P = .022). Comparing those who did (n = 78) and did not (n = 8) have a TBI history, there were no significant differences in median change in VFQ-25 composite scores (with TBI: 2.3 vs. no TBI: 10.7; P = .179). Participants with a TBI history had a significantly lower median SF-36 General Health score (with TBI: 67.5 vs. no TBI: 92.5; P = .009) Conclusions Vision-related QOL of COT patients is generally good in the long term. However, those with both COT and a history of TBI conditions showed significantly worse functioning in several domains than those without TBI. As TBI is a common finding in COT, this association is an important factor impacting this population’s overall clinical presentation and daily functions.


PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0257981
Author(s):  
Jung-Hwa Ryu ◽  
Tai Yeon Koo ◽  
Han Ro ◽  
Jang-Hee Cho ◽  
Myung-Gyu Kim ◽  
...  

Renal functional deterioration is associated with physical and mental burdens for kidney transplant (KT) and chronic kidney disease (CKD) patients. However, the change in health-related quality of life (HRQOL) over time in KT patients compared to that of native CKD patients has not been evaluated. We addressed this issue using KT patients registered in the KNOW-KT cohort study and patients at CKD stage 1–3 registered in the KNOW-CKD cohort study. HRQOL scores were assessed using the Kidney Disease Quality of Life Short Form at baseline, 2-, and 4-years follow-up in 842 KT patients and at baseline and 5-year follow-up in 1,355 CKD patients. SF-36 scores declined at the 4-year follow-up, whereas CKD-targeted scores showed no change in the KT group. In contrast, CKD-targeted scores as well as SF-36 scores were decreased at the 5-year follow-up in CKD patients. When prognostic factors were analyzed for longitudinal HRQOL data over time, renal functions, diabetes, cardiovascular and cerebrovascular diseases, hemoglobin level, marital status, income, employment, and health care were significant prognostic factors. Furthermore, KT was an independent prognostic factor for better HRQOL. These results highlight that KT can offer a better HRQOL than that of CKD patients, even when renal function is similar.


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
F Bianco ◽  
M Colaneri ◽  
V Bucciarelli ◽  
FC Surace ◽  
FC Iezzi ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background  To compare long-term outcomes of aortic valve repair (AVr) and pulmonary autograft replacement (Ross procedure) in terms of echocardiographic parameters, quality of life (QoL), physical activity (PA). Methods  In 2005-19, 129 patients (median age 22 [13, 33 IQR], 75% males) underwent aortic surgery in our Department: 40 were Ross (22 years [19, 51 IQR]), 67 AVr (17 years [1, 50 IQR]) and 22 aortic valve replacements (52 years [30, 80 IQR]). We focused on Ross and AVr. Retrospectively, relevant data were collected from medical records and phone re-calls. Physical activity (spontaneous and active) and QoL were assessed utilizing the IPAQ and SF-36 questionnaires. All patients underwent echocardiography pre/post-surgery and the follow-up lasted 12 ± 4 years. Results  At the baseline, Ross patients had more aortic stenosis than insufficiency (P = 0.045). At the follow-up, Ross procedures presented more right-ventricle and aortic annulus dilatation (P = 0.002 and P = 0.030, respectively), but higher left-ventricular global longitudinal strain (LV GLS: 18 ± 3.2 % vs. 16 ± 3.3, P = 0.0027). Conversely, AVr experienced more re-do operations (Log-rank P = 0.005). Ross reported better QoL (SF-36: 0.8 ± 0.07 vs. 19 ± 0.4, P-0.045) and were also more active in daily PA (IPAQ ≥ 2500 Mets: 63.8% vs. 6%; P = 0.006). Ross patients practiced more sports activities than AVr (P = 0.011). Conclusions  In a relatively small cohort of young and adults post aortic surgery patients, Ross procedures had better prognosis in terms of re-do operations; presented better ventricular function, as assessed by LV GLS. Ross patients had better long-term QoL and showed more spontaneous PA and involvement in sports activity.


2021 ◽  
Vol 7 (3) ◽  
pp. 24-27
Author(s):  
S. Tokareva ◽  
R. Kupeev ◽  
Aleksandr Hadarcev ◽  
Sof'ya Belyaeva

The purpose of the work. To show the expediency of using a complex DPN therapy with thio-gammoy-600 in combination with TPP, B12-ankerman and febuxostat. Materials and research methods. The study involved 28 male patients suffering from DM2 aged 56-77 years, with an av-erage age of 64.6±0.7 years. The initial values of average fasting blood glucose were 7.8 ± 1.52 mmol/l, glycosylated hemoglobin 7.4 ± 0.13%. Two groups were identified: group 1 (main) – 14 people and group 2 (control) - 16 people. In group 2, basic DPN therapy was used (thiogamma 600 mg/day for 4 months). For the first 14 days, the drug was administered intravenously, and then administered orally. In group 1, in addition to basic DPN therapy, B12-ankerman and febuxostat (adenuric) – 80 mg/day were received. TPP was carried out on a portable device TPP-03 for 15 minutes daily. This treatment regimen was used for 4 months. The assessment of the quality of life (QL) was carried out using the MOS SF-36 questionnaire. Results and their discussion. Four months after the start of therapy, more pronounced changes were observed in patients of the first group. The total score of the NSS scale in this group increased by 28.9%, and in group 2 - by 18.8%. The positive effect of therapy with adenuric and TES on the course of DPN shows that the use of this treatment will naturally lead to an improve-ment in the quality of life of patients, the dynamics of which was studied according to the results of the SF-36 questionnaire.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Christina L Wassel ◽  
Matthew A Allison ◽  
Joachim H Ix ◽  
Julie O Denenberg ◽  
Dena E Rifkin ◽  
...  

Background: Lower extremity peripheral artery disease (PAD) affects approximately 9 million people in the US. Less well-recognized is that PAD, even when asymptomatic, is associated with decreased functional status and quality of life. Previous studies have largely examined associations of the ankle brachial index (ABI) and quality of life in participants with PAD. To our knowledge no studies have examined the impact of ABI and change in ABI on change in quality of life in a population-based setting. Methods: The SDPS is a population-based prospective study that evaluated non-Hispanic White, African-American, Hispanic and Asian men and women for lower extremity PAD at two examinations approximately 11 years apart. Participants completed the SF-36 questionnaire, and 802 participants had ABI and SF-36 data available at both examinations. Analyses were restricted to these participants who also had a baseline ABI<1.4. Growth curve models were used to assess the associations of baseline ABI and change in the ABI with change in the SF-36 physical component score (PCS) and mental component score (MCS) over time. Change in the ABI was defined as (follow-up ABI - baseline ABI)/baseline ABI. Results: Participants were on average 57±9 years of age at baseline, and 69±9 at follow-up. At baseline, nearly 2 percent had ABI≤0.90, and the mean±SD ABI was 1.12±0.10. After adjustment for age, sex, race/ethnicity, BMI, ever smoking, physical activity, hypertension, diabetes, and dyslipidemia, each SD lower baseline ABI was significantly associated with an average change of -0.63 points (95% CI (-0.10, -1.17), p=0.02) on the PCS. This association was marginally significant for the MCS (-0.54 points (0.14, 1.22), p=0.12). Lower baseline ABI was also associated with negative change in two SF-36 subscales, physical functioning (p=0.02) and vitality (p=0.01). Change in the ABI over 11 years was not associated with change in the MCS (p=0.97) or PCS (p=0.41). Results were similar when excluding participants with ABI≤0.90. Conclusions: A lower ABI at baseline is associated with a significantly worse physical functioning quality of life approximately 11 years later. However change in the ABI was not significantly associated with change in quality of life over this time period. Additional studies are warranted in larger samples, especially to confirm the lack of findings for change in ABI.


2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii12-ii13
Author(s):  
S M Keshwara ◽  
A I Islim ◽  
C P Millward ◽  
C S Gillespie ◽  
G E Richardson ◽  
...  

Abstract BACKGROUND Long-term Health-Related Quality of Life (HRQoL) is an important measure of patient wellbeing. There is a paucity of studies evaluating HRQoL in meningioma patients. MATERIAL AND METHODS Cross-sectional study of adult patients with an incidental or symptomatic intracranial meningioma. Patients with less than 5 years of follow-up, a history of craniospinal radiation or neurofibromatosis type 2 were excluded. HRQoL was evaluated with SF-36, EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Outcome determinants were evaluated using a multi-variable linear regression analysis, adjusted for patient, tumour and treatment characteristics, and duration of follow-up. RESULTS 699 patients were invited to participate and 246 responded: 118 (48%) had an incidental meningioma. Mean age at diagnosis was 56.8 years (SD=13) and 81% were female. Median time from diagnosis to completion of questionnaire was 8.5 years (IQR 6.8–11.5). During follow-up, 158 patients (64.2%) had at least one operation for their meningioma and 47 patients (19.1%) had radiotherapy. Of those operated, 126 (79.7%) had WHO grade 1 and 24 (15.2%) had grade 2 meningiomas. Compared to normative population values, meningioma patients reported a worse SF-36 general health score (mean 61.9 vs 56.5, P=0.003) but a similar QLQ-C30 global health score (mean 62.3 vs 65.8, P=0.039), worse SF-36 and QLQ-C30 physical functioning scores (mean 74.1 vs 64.6, P&lt;0.001 and mean 81.8 vs 76.5, P=0.007) and similar SF-36 and QLQ-C30 emotional health scores (mean 72.2 vs 70.9, P=0.367 and mean 71.0 vs 71.9, P=0.960). QLQ-C30 cognitive functioning was worse (mean 80.5 vs 71.4, P&lt;0.001). Compared to the meningioma literature, QLQ-BN20 seizure burden was similar (mean 2.0 vs 1.6, P=0.760). A worse performance status at diagnosis was associated with an inferior QLQ-C30 global health score (β-coefficient=-4.9 [95% CI -9.1-(-)0.6] P=0.024). Number of surgeries was significantly associated with a worse QLQ-C30 cognitive functioning score (β-coefficient=-7.0 [95% CI -13.2-(-)0.9], P=0.025). Anti-epileptic drug use was associated with a significantly worse QLQ-C30 emotional health score (β-coefficient=-10.9 [95% CI -21.7-(-)0.01], P=0.050). CONCLUSION Meningioma patients have long-term HRQoL impairments affecting their physical and cognitive functions. An understanding that multiple surgeries affects cognitive function, and the need for anti-epileptic drugs equate to poorer emotional health, could help target appropriate therapies and support in the future.


ESC CardioMed ◽  
2018 ◽  
pp. 1030-1035
Author(s):  
Mike Kirby ◽  
Jonny Coxon

It should not be presumed that male patients with cardiovascular disease are less sexually active than others, but they are more likely to have erectile dysfunction. It is therefore crucial to consider the impact on sexual function of medications commonly used to treat cardiovascular disease, because negative effects on erectile dysfunction can lead to problems with compliance and quality of life. Cardiovascular implications of phosphodiesterase type 5 inhibitors used to treat erectile dysfunction should be borne in mind. Effective treatment of the cardiac condition should always take priority.


2017 ◽  
Vol 37 (4) ◽  
pp. 320-327
Author(s):  
P.A. Oddon ◽  
M. Montava ◽  
F. Salburgo ◽  
M. Collin ◽  
C. Vercasson ◽  
...  

L’obiettivo di questo lavoro è stato di valutare la storia naturale di crescita degli schwannomi vestibolari (VS), la qualità di vita di quelli trattati in maniera conservativa e di validare una scala specifica per tale malattia in lingua francese, Penn Acoustic Neuroma Quality-of- Life (PANQOL). Sono stati studiati retrospettivamente 26 pazienti con VS trattato in maniera conservativa. Sono state raccolte le caratteristiche dei pazienti e i reperti radiologici, e sono state utilizzate due scale per validare valutare la qualità di vita: la Short Form-36 Health Survey (SF-36) e la PANQOL scale, tradotta in francese. I punteggi ottenuti sono stati comparati con gli studi precedenti. Il tempo medio di follow up è stato di 25 mesi (range 6-72). È stata osservato un accrescimento del tumore in 14 pazienti (53,8%), nessun accrescimento in 12 pazienti (46,2%), e non si è verificata nessuna riduzione. La crescita media del tumore è stata di 2,22 mm/anno, e non sono stati individuati fattori predittivi di crescita. I pazienti con vertigini e instabilità hanno riferito una più bassa qualità di vita, sia secondo la scala SF-36, sia secondo la scala PANQOL. Utilizzando la scala SF-36, i nostri risultati si sono rivelati paragonabili a quelli della letteratura. Utilizzando la scala PANQOL, i nostri punteggi non si sono rivelati statisticamente diversi da quelli derivanti da studi tedeschi e nordamericani, ad eccezione di quelli riguardanti l’udito (p=0,019). La qualità di vita diventa sempre più importante nella gestione dei VS. In linea con questi risultati, noi sosteniamo la strategia non conservativa associata ad una riabilitazione vestibolare per quei pazienti con vertigini ed instabilità. La scala PANQOL, disponibile in lingua francese, si è rivelata specifica per i VS.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Min-hao Wu ◽  
Ling-fei Xiao ◽  
Fei-fei Yan ◽  
Shi-Liang Chen ◽  
Chong Zhang ◽  
...  

Abstract Objective The present study aimed to evaluate the short-term clinical performance and safety of percutaneous microwave ablation (MWA) techniques for the treatment of bone tumors. Methods This single-institution retrospective study investigated 47 cases of bone tumors treated by MWA from June 2015 to June 2018. The study included 26 patients (55.3%) with benign bone tumors and 21 patients (44.7%) with malignant bone tumors. The tumors were located in the spine or sacrum (15, 31.9%), the upper extremities (6, 12.8%), the lower extremities (17, 36.2%) and the pelvis (9, 19.1%). Outcomes regarding clinical efficacy, including pain relief, quality of life, and intervention-related complications, were evaluated before and after MWA using the visual analog scale (VAS) and the 36-item Short-Form Health Survey (SF-36) scoring system. Results Of the 47 patients included in this study, all of them completed follow-up examinations, with a mean follow-up duration of 4.8 ± 1.6 months (range, 2–9 months). Significantly improved VAS and SF-36 scores were recorded after the initial treatment (P<0.001), suggesting that almost 100% of patients experienced pain relief and an improved quality of life following surgery. No major intervention-related complications (e.g., serious neurovascular injury or infection) occurred during or after the treatment. We recorded only three minor posttreatment complications (6.4%, 3/47), which were related to thermal injury that caused myofasciitis and affected wound healing. Conclusion In our study, the short-term efficacy of MWA was considerably favorable, with a relatively low rate of complications. Our results also showed that MWA was effective for pain relief and improved patients’ quality of life, making it a feasible treatment alternative for bone tumors.


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